Clinical Trial of Hysteroscopy in Postmenopausal Women to... | NCT01376934

Studies
Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques

NCT01376934

Sponsor

University of Campinas, Brazil

Status

Unknown status

Last Update Posted

Jun 20, 2011Estimated

Enrollment

140Estimated

Phase

Not Applicable

Conditions

Postmenopausal Women
Hysteroscopy

Interventions

procedure hysteroscopy

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Mar 2011Actual

Completion Date

Not provided

First Submitted Date

Jun 16, 2011

First Submission Date that Met QC Criteria

Jun 17, 2011

First Posted Date

Jun 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2011

Last Update Posted Date

Jun 20, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Nowadays,hysteroscopy is a golden standard procedure to describe the morphology of uterine cavity and investigate of abnormal uterine bleeding . The success of the procedure is based on the distension of the cavity . It can cause pain and discomfort and sometimes the procedure fails. . There are two techniques to make the procedure , one with gas and the other with saline solution. Objective: to compare two techniques concerning pain , procedure duration and image quality

Detailed Description

The objective of this study is to compare two techniques in office hysteroscopy.In this clinical trial postmenopausal women will undergo a diagnostic hysteroscopy using carbon dioxide or saline solution to uterine cavity distension.

There will be two groups of 70 women each. The objective is to determine which technique provides better image,time of procedure and less discomfort.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
procedure hysteroscopy	Procedure	office hysteroscopy with gas or saline solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the comfort in office hysteroscopy	140 women will undergo office hysteroscopy to evaluate pain, time of the procedure and image quality using two techniques one with gas and the other with saline solution.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women post-menopausal with abnormal uterine bleeding, ultrasound with thick endometrial distorted

Exclusion Criteria:

Women with uterine malformations
Women with mental retardation
Women underwent pelvic radiotherapy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Valter Fausto Santos	University of Campinas, Brazil	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departamento de Tocoginecologia FCM UNICAMP	Recruiting	Campinas	São Paulo	13083881	Brazil